Overview
CEN ISO/TR 22100-1:2021 - Safety of machinery: Relationship with ISO 12100 (Part 1) - explains how the type‑A standard ISO 12100 relates to type‑B and type‑C machinery safety standards. Published as a Technical Report by ISO/TC 199 in collaboration with CEN/TC 114, this document helps designers, manufacturers and standards committees apply the system of standards to achieve adequate risk reduction and a level of tolerable (residual) risk for actual machines.
Key topics
- Role of ISO 12100 (type‑A): Explains general principles for risk assessment and risk reduction and how ISO 12100 underpins the machinery safety standards system.
- Type‑B and type‑C standards: Describes categories of type‑B standards (B1/B2), and the function and expected content of type‑C standards, including how they can deviate from type‑B guidance where appropriate.
- Practical methodology (Clause 6): Provides detailed guidance on applying ISO 12100 together with relevant type‑B and type‑C standards to design machines with acceptable residual risk. Includes stepwise approaches to select and evaluate type‑C standards for a specific machine.
- Harmonized standards and EU law: Annex ZA explains the relation to the EU Machinery Directive 2006/42/EC and how correct application of harmonized type‑C standards can confer a presumption of conformity with essential requirements.
- Supportive material: Visual representations of standards interrelationships, an iterative risk‑assessment annex, and a normative reference to ISO 12100:2010.
Applications
Who uses ISO/TR 22100-1:2021 and why:
- Machine designers and manufacturers: To identify which standards apply, integrate ISO 12100 risk‑reduction principles with specific type‑C requirements, and document that residual risk is tolerable.
- Standards committees and writers: To understand how to structure type‑B and type‑C standards and ensure consistency with ISO 12100’s risk assessment framework.
- Compliance and safety engineers: To assess whether applying a harmonized (type‑C) standard provides presumption of conformity with the EU Machinery Directive and to justify deviations or additional safeguards.
- Regulatory and conformity assessment bodies: For interpreting the linkage between technical standards and essential health and safety requirements.
Related standards and guidance
- ISO 12100:2010 - normative reference for general principles of risk assessment and reduction.
- Machinery Directive 2006/42/EC - Annex ZA discusses presumption of conformity when harmonized standards are correctly applied.
- ISO/TR 22100‑1 is part of the ISO/TR 22100 series and complements guidance on navigating type‑A/B/C standards and implementing practical risk‑reduction measures.
Keywords: ISO/TR 22100-1:2021, safety of machinery, ISO 12100, type-B standards, type-C standards, risk assessment, risk reduction, Machinery Directive 2006/42/EC, harmonized standards, presumption of conformity.